Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
  • A61K8/34—Alcohols
  • A61K8/347—Phenols
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
  • A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/10—Anti-acne agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/10—Antimycotics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
  • A61Q17/005—Antimicrobial preparations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/08—Anti-ageing preparations

Definitions

• the present invention relates to a composition
• a composition comprising at least one phytocomplex derived from the water from pressing olives for oil and/or pomace oil residues of the olive milling process, and/or a polyphenolic residue and/or olive oil and the cosmetic use thereof.
• the bodily tissues of the human body are subjected to stress daily due to the outside environment.
• the skin is the outermost tissue, which covers both the external and internal body surfaces.
• the skin is the organ with the most extensive surface, and it has a protective, sensory, secretory, thermoregulating, absorption, permeability and aesthetic function.
• Skin hygiene and skin care against causes of potential damage represent essential elements of prevention.
• the skin is also affected by dietary, addictive and work habits, and the intake of drugs.
• many diseases of an internal type have skin manifestations.
• oxidative stress that is, an imbalance between the production and elimination of the oxidising substances produced by our body, better known as free radicals.
• Free radicals or more correctly reactive oxygen species (OS)
• OS reactive oxygen species
• the free radicals thus produced are unstable species that need to bind with cell structures in order to be able to stabilise.
• a cell for example to DNA, proteins or lipids
• Oxidation renders the cell sensitive to premature aging processes and degradation. Preventing the onset of oxidative stress is thus fundamental in order to reduce the effects of time on the body and combat any degenerative diseases.
• the present invention fits into this context; it relates to a composition comprising at least one phytocomplex or concentrate derived from the water from pressing olives for oil and/or pomace oil residues of the olive milling process comprising high quantities of hydroxytyrosol and oleuropein-aglycone di-aldehyde (3,4-DHPA-EDA), a polyphenolic residue and olive oil and the use thereof in the cosmetic field for the prevention and/or treatment of skin aging.
• the Applicant has surprisingly found that, by applying the composition of the invention, in particular in the form of a cream, it is possible to improve/attenuate the signs of skin aging.
• the application of the cream favours cell renewal, and combats and mitigates the oxidative stress caused by free radicals.
• composition acts against pathogenic agents, for example against bacteria and/or against fungi.
• FIG. 1 shows a graph of the pre-analysis of the production of IL-8 by HaCaT cells following treatment with 10 ng/mL TNF- ⁇ pr 24, 48 and 72 hours and in co-stimulation with hydrocortisone;
• FIG. 5 shows the analysis of the antimicrobial activity of the polyphenolic concentrate by reverse osmosis on different microorganisms
• FIG. 6 shows the quantification of the zones of inhibition formed, according to the microorganism tested and its initial mass in the perforation test and the plate test.
• a first aspect of the present invention relates to a composition
• a composition comprising at least one excipient acceptable for pharmaceutical and/or cosmetic use, a phytocomplex or concentrate rich in hydroxytyrosol and oleuropein- aglycone di-aldehyde (3,4-DHPA-EDA), and a polyphenolic residue and optionally olive oil.
• the phytocomplex or natural concentrate of the present invention is derived from the water from pressing olives for oil and/or pomace oil residues of the olive milling process.
• this concentrate or phytocomplex is particularly rich in hydroxytyrosol and oleuropein-aglycone di-aldehyde (3,4-DHPA-EDA).
• the amount of hydroxytyrosol preferably ranges from 0.2 to 2 grams per litre of vegetation water (g/L), more preferably from 0.25 to 1 g/L, even more preferably from 0.3 to 0.9 g/L.
• the amount of 3,4-DHPA-EDA is preferably comprised from 0.2 to 3 g/L, more preferably from 0.3 to 2 g/L, even more preferably from 0.4 to 1.5 g/L.
• the vegetation water is preferably derived from a three-phase (oil, vegetation water and pomace), and/or a two-phase (oil and pomace + vegetation water) olive milling process.
• the vegetation water generated by the mill can be treated with a solution with an acidic pH preferably ranging from 3 to 5; more preferably, the pH is about 4-5.
• the pH is preferably optimised by adding a strong acid and/or pectolytic enzymes, i.e. enzymes that hydrolyse the cellulose matrix of olive skins.
• the pomace is pitted, diluted and/or pre-filtered.
• the pomace preferably has a particle size ranging from 0.5 to 1 millimetre (mm), more preferably about 0.7 mm. An example of a particle size is the one obtained by sieving with a vibrating screen.
• the pitted pomace may optionally be solubilised and/or dispersed in an aqueous matrix with a pH comprised preferably from 3 to 5, more preferably from 3.5 to 4.
• the solubilisation step has the purpose of solubilising the polyphenols that would otherwise remain trapped in the solid matrix of the olive skins.
• the concentrate comprises:
• a further phenolic compound preferably selected from: tyrosol, hydroxytyrosol, hydroxytyrosol glucoside, caffeoyltownoganoside, oleuropein, p-coumaroyl-secologanoside, chlorogenic acid, ⁇ -hydroxy verbascoside, rutin, verbascoside, luteolin and combinations thereof; and/or
• - at least one metal preferably selected from: sodium, calcium, magnesium and potassium and combinations thereof; and/or - at least one anion, preferably selected from: chlorides, sulphates, phosphates and nitrates and combinations thereof; and/or
• glucide selected from: glucose, fructose, mannitol and sucrose and combinations thereof.
• the concentrate comprises nitrogenous substances (proteins, amino acids), preferably in an amount comprised from 15 to 60 mg/kg, more preferably from 20 to 40 mg/kg (mg of nitrogen per litre of active solution).
• the amount of the hydroxytyrosol glucoside preferably ranges from 0.2 to 2 grams per litre of vegetation water (g/L), more preferably from 0.25 to 1 g/L, even more preferably from 0.3 to 0.9 g/L.
• the amount of caffeoyltownoganoside is preferably comprised from 0.05 to 0.6 g/L, more preferably from 0.08 to 0.5 g/L.
• the amount of oleuropein is preferably comprised from 0.05 to 0.6 g/L, more preferably from 0.08 to 0.5 g/L.
• the amount of p-coumaroyl-secologanoside is preferably comprised from 0.05 to 0.6 g/L, more preferably from 0.08 to 0.5 g/L.
• the amount of tyrosol is preferably comprised from 0.1 to 0.7 g/L, more preferably from 0.15 g/L and 0.5 g/L.
• the amount of chlorogenic acid is preferably comprised from 0.06 to 0.7 g/L, more preferably from 0.1 to 0.6 g/L.
• the amount of ⁇ -hydroxy verbascoside is preferably comprised from 0.1 to 1.5, more preferably from 0.3 to 1 g/L.
• the amount of rutin is preferably comprised from 0.05 to 0.6 g/L, more preferably from 0.08 to 0.5 g/L.
• the amount of verbascoside is preferably comprised from 0.1 to 1.5 g/L, more preferably from 0.3 to 1 g/L.
• the amount of luteolin is preferably comprised from 0.1 to 1.5 g/L, more preferably from 0.3 to 1 g/L.
• the amount of sodium is preferably comprised from 75 to 300 mg/L, more preferably from 120 to 180 mg/L.
• the amount of calcium is preferably comprised from 5 to 10 g/L, more preferably from 2 to 5 g/L.
• the amount of magnesium is preferably comprised from 220 to 900 mg/L, more preferably from 400 to 500 mg/L.
• the amount of potassium is preferably comprised from 3 to 15 g/L, more preferably from 6 to 9 g/L.
• the amount of chlorides is preferably comprised from 1.5 to 7 g/L, more preferably from 2.5 to 4.5 g/L.
• the amount of sulphates is preferably comprised from 12 to 45 g/L, more preferably from 18 to 28 g/L.
• the amount of phosphates is preferably comprised from 1.5 to 7 g/L, more preferably from 2.5 to 5 g/L.
• the amount of nitrates is preferably comprised from 12 to 50 mg/L, more preferably from 18 to 30 mg/L.
• the amount of glucose is preferably comprised from 15 to 60 g/L, more preferably from 25 to 35 g/L.
• the amount of fructose is preferably comprised from 3.5 to 15 g/L, more preferably from 5 to 9 g/L.
• the amount of mannitol is preferably comprised from 1 to 4 g/L, more preferably from 1.5 to 3 g/L.
• the amount of sucrose is preferably comprised from 4 to 16 g/L, more preferably from 6 to 10 g/L.
• composition comprises at least one excipient acceptable for pharmaceutical and/or cosmetic use and:
• the polyphenolic concentrate in an amount comprised from 0.01 to 30 wt%, preferably from 0.05 to 25 wt%;
• the polyphenolic residue in an amount comprised from 2 to 98 wt%, preferably from 4 to 96 wt%;
• the composition of the present invention comprises the polyphenolic concentrate in an amount comprised from 0.01 to 30 wt%, preferably from 0.05 to 25 wt%, and olive oil in a concentration comprised from 1 wt% to 10 wt%, more preferably from 3 wt% to 7 wt%.
• the concentrate is obtained/obtainable by means of a process comprising the steps of:
• step (ii) concentrating the microfiltration permeate obtained from step (i) by means of reverse osmosis.
• the microfiltration is performed after the solubilisation step as described before.
• the microfiltration has the purpose of separating a concentrate, i.e. the concentrated fraction of the content of the vegetation water/pomace in suspension, for example micro fragments, fibres and corpuscular material such as cells and bacteria. It is carried out under the standard conditions for this type of matrix.
• a permeate i.e. a clear fraction, characterised by a colour that varies according to the starting material and contains the dissolved components of the vegetation water/pomace, e.g. proteins, sugars, salts, polyphenols, organic acids and various soluble organic molecules.
• the microfiltration is preferably carried out with at least one, preferably two, ceramic membrane(s).
• the membrane is characterised by a preferably tubular shape.
• the membrane is made of alumina and zirconia oxide. According to a preferred aspect of the invention, the membrane has the following characteristics:
• a series of channels with a diameter, preferably a hydraulic diameter, ranging from about 2.5 to about 5 mm, preferably of about 3.5 mm;
• a filtering surface ranging from about 0.15 to about 0.7 m 2 , preferably of about 0.35 m 2 ;
• a molecular size ranging from about 0.1 micron to about 300 kDa.
• the membrane when the membrane is made of ceramic material it is extremely resistant to high temperatures and/or extreme pH conditions and is thus particularly suitable for the vegetation water treatment process, which, as it causes a high degree of "dirtying" on the membrane, requires high-temperature washing under severe pH conditions (e.g. pH 13-14).
• the membrane when the membrane has a tubular conformation, it allows back pulse washing, which is a further system for reconditioning and long- term operation.
• the reverse osmosis step for concentrating the permeate obtained from the microfiltration of the vegetation water/pomace as described before is carried out under the standard conditions for this type of matrix, preferably by using a polymeric membrane, more preferably made of polyamide.
• the membrane preferably has a spiral-wound conformation and/or a molecular weight cut-off with high salt rejection, i.e. capable of rejecting sodium chloride molecules at a percentage of 99.9 %. This means that the osmosis membrane holds back the molecules of biomedical interest and allows only water molecules to pass through.
• the polymeric membrane preferably has a filtering surface ranging from about 5 to about 15 m 2 , more preferably of about 7 m 2 .
• the reverse osmosis step enables the permeate obtained by microfiltration to be concentrated preferably by about 4 times; this means that from 100 L of microfiltration permeate 25 L of concentrate are obtained.
• the volume concentration ratio (VCR) is 4, i.e. 100/25.
• the VCR can change based on the starting matrix (vegetation water) and above all based on its salt content, because the reverse osmosis process must offset the osmotic pressure of the matrix which is going to be concentrated.
• polyphenolic residue or "Olea Europaea Fruit Water” (hereinafter “polyphenolic residue”) is preferably derived from a three-phase (oil, vegetation water and pomace) and/or two-phase (oil and pomace + vegetation water) olive milling process, microfiltered and concentrated by reverse osmosis with the process as described above.
• Said polyphenolic residue is a clear, limpid fraction which contains the dissolved components of the vegetation water/pomace, e.g. proteins, sugars, salts, polyphenols, organic acids and various soluble organic molecules in limited amounts.
• the polyphenolic residue comprises: at least one phenolic compound preferably selected from: tyrosol, hydroxytyrosol, hydroxytyrosol glucoside, caffeoyltownoganoside, oleuropein, p-coumaroyl-secologanoside, chlorogenic acid, ⁇ -hydroxy verbascoside, rutin, verbascoside, luteolin and combinations thereof.
• Said polyphenolic residue mainly composed of water, in which numerous active ingredients are dissolved, as described above, can be used as a solvent to partially replace water for the preparation of the composition.
• the olive oil is an edible oil extracted from olives, i.e. the fruits of the olive tree (Olea europaea), preferably by mechanical pressing. Said olive oil is obtained by means of standard milling and/or extraction and/or separation and/or storage and/or clarification techniques.
• the olive oil comprises squalene, saturated, monounsaturated and polyunsaturated fatty acids, omega 3 and omega 6 fatty acids, phthalates, mineral oils, alkyl esters, tocopherols, polycyclic aromatic hydrocarbons and combinations thereof.
• the fatty acids are preferably selected from: palmitic acid (C16:0), palmitoleic acid (C16:1 ), heptadecanoic acid (C17:0), heptadecenoic acid (C 17:1 ), stearic acid (C18:0), oleic acid (C18:1 n-9), vaccenic acid (C18:1 n-7), linoleic acid (C18:2 n-6), alpha-linolenic acid (C18:3 n-3), arachidic acid (C20:10), eicosenoic acid (C20:1 n-9), behenic acid (C22:0) and combinations thereof.
• the phthalates are preferably selected from butyl-benzyl-phthalate, di- isononyl phthalate and combinations thereof.
• the mineral oils are preferably selected from: MOAH (Mineral Oil
• Aromatic Hydrocarbons C10-35, MOSH (Mineral Oil Satured
• Hydrocarbons C10-35 and combinations thereof.
• the alkyl esters are preferably selected from: ethyl linoleate, ethyl oleate, ethyl stearate, methyl oleate and combinations thereof.
• the olive oil comprises squalene in an amount comprised from 1000 mg/kg to 5000 mg/kg, more preferably from
• the ratio between polyunsaturated fatty acids and monounsaturated fatty acids is preferably comprised from 0.08 to 0.2, preferably from 1 to 1.7.
• the ratio between polyunsaturated fatty acids and saturated fatty acids is preferably comprised from 0.06 to 1 , preferably from 0.1 to 0.9.
• the amount of palmitic acid is preferably comprised from 8 to 20 wt%, more preferably from 10 to 18 wt%.
• the amount of palmitoleic acid is preferably comprised from 0.4 to 4 wt%, more preferably from 0.8 to 2 wt%.
• the amount of heptadecanoic acid is preferably comprised from 0.01 to 1 wt%, more preferably from 0.03 to 0.3 wt%.
• the amount of heptadecenoic acid is preferably comprised from 0.07 to 1 wt%, more preferably from 0.09 to 0.5 wt%.
• the amount of stearic acid is preferably comprised from 1 to 7 wt%, more preferably from 1.3 to 4 wt%.
• the amount of oleic acid is preferably comprised from 40 to 90 wt%, more preferably from 50 to 80 wt%.
• the amount of vaccenic acid is preferably comprised from 1 to 7 wt%, more preferably from 1.3 to 4 wt%.
• the amount of linoleic acid is preferably comprised from 3 to 15 wt%, more preferably from 5 to 12 wt%.
• the amount of alpha-linolenic acid is preferably comprised from 0.2 to 2 wt%, more preferably from 0.3 to 1 wt%.
• the amount of arachidic acid is preferably comprised from 0.1 to 2 wt%, more preferably from 0.2 to 1 wt%.
• the amount of eicosenoic acid is preferably comprised from 0.1 to 2 wt%, more preferably from 0.2 to 1 wt%.
• the amount of behenic acid is preferably comprised from 0.07 to 1 wt%, more preferably from 0.09 to 0.5 wt%.
• the saturated fatty acids are preferably present in an amount comprised from 8 g/100g to 30 g/100g, more preferably from 10 g/100g to 20 g/100g.
• the monounsaturated fatty acids are preferably present in an amount comprised from 40 g/100g to 90 g/100g, more preferably from 50 g/100g to 80 g/100g.
• the polyunsaturated fatty acids are preferably present in an amount comprised from 3 g/100g to 20 g/100g, more preferably from 7 g/100g to 17 g/100g.
• the omega 3 fatty acids are preferably present in an amount comprised from 0.1 wt% to 2 wt%, more preferably from 0.3 wt% to 1 wt%.
• the omega 6 fatty acids are preferably present in an amount comprised from 3 to 15 wt%, more preferably from 5 to 12 wt%.
• the ratio between omega 3 and omega 6 is preferably comprised from 0.07 to 1 , more preferably from 0.09 to 0.5.
• the amount of butyl-benzyl-phthalate is preferably comprised from 0.2 to 2 wt%, more preferably from 0.3 to 1 wt%.
• the amount of di-isononyl phthalate is preferably comprised from 1 to 7 wt%, more preferably from 1.3 to 4 wt%.
• the amount of MOAH is preferably comprised from 0.4 to 4 wt%, more preferably from 0.8 to 2 wt%.
• the amount of MOSH is preferably comprised from 2 to 10 wt%, more preferably from 3 to 8 wt%.
• the ethyl linoleate is preferably present in an amount comprised from 0.5 wt% to 3 wt%, more preferably from 1 wt% to 2.5 wt%.
• the ethyl oleate is preferably present in an amount comprised from 1 wt% to 3.5 wt%, more preferably from 1.5 wt% to 3 wt%.
• the ethyl stearate is preferably present in an amount comprised from 0.5 wt% to 3 wt%, more preferably from 1 wt% to 2.5 wt%.
• the methyl oleate is preferably present in an amount comprised from 1 wt% to 10 wt%, more preferably from 3 wt% to 8 wt%.
• composition of the present invention comprises at least one excipient acceptable for pharmaceutical use and/or cosmetic use, which is useful in the preparation of the composition and is generally biologically safe and non-toxic.
• Said excipient can be at least one conditioning agent, preferably a skin humectant, occlusive or emollient conditioning agent.
• Said conditioning agent is preferably selected in the group consisting in: glycerine, hyaluronic acid, caprylic/capric triglyceride, aspartic acid, decyl cocoate, soybean oil, lactic acid, glyceryl stearate, beeswax, glyceryl behenate, glyceryl dibehenate, tribehenin, betaine and stearic acid and combinations thereof.
• the concentration of said conditioning agent preferably ranges from 5 to 45 wt%, preferably from 10 to 30% wt.
• the concentration of said glycerine preferably ranges from 0.25 to 15 wt%; more preferably, it ranges from 0.3 to 13 wt%.
• the concentration of said hyaluronic acid preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.7 to 4 wt%.
• the concentration of said decyl cocoate preferably ranges from 0.5 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.
• the concentration of said beeswax preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.7 to 4 wt%.
• the concentration of said stearic acid preferably ranges from 0.05 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.
• the concentration of said glyceryl stearate preferably ranges from 0.05 to
• the concentration of said caprylic/capric triglyceride preferably ranges from 0.5 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.
• the concentration of said lactic acid preferably ranges from 0.005 to 5 wt%; more preferably, it ranges from 0.008 to 3 wt%.
• the concentration of said soybean oil preferably ranges from 0.005 to 5 wt%; more preferably, it ranges from 0.008 to 3 wt%.
• the concentration of said glyceryl behenate preferably ranges from 0. 05 to 5 wt%; more preferably, it ranges from 0. 08 to 3 wt%.
• the concentration of said glyceryl dibehenate preferably ranges from 0.1 to 7 wt%; more preferably, it ranges from 0.2 to 5 wt%.
• the concentration of said tribehenin preferably ranges from 0.1 to 7 wt%; more preferably, it ranges from 0.2 to 5 wt%.
• the concentration of said betaine preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.08 to 3 wt%.
• Said excipient can further be a surfactant agent, preferably an emulsifying or cleansing surfactant agent.
• Said surfactant agent is preferably selected in the group consisting in: cetyl stearyl alcohol, cetyl alcohol, polyglyceryl-3 dicitrate/stearate and combinations thereof.
• concentration of said surfactant agent preferably ranges from 0.5 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.
• the concentration of said cetyl stearyl alcohol preferably ranges from 0.5 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.
• the concentration of said plolyglyceryl-3 dicitrate/stearate preferably ranges from 1 to 10 wt%; more preferably, it ranges from 2 to 7 wt%.
• Said excipient can further be a binder, preferably selected from dextrins, preferably distarch phosphate, or else a stabilising agent, preferably an emulsifying stabilising agent, such as, for example, xanthan gum.
• a binder preferably selected from dextrins, preferably distarch phosphate, or else a stabilising agent, preferably an emulsifying stabilising agent, such as, for example, xanthan gum.
• concentration of said binder preferably ranges from 0.05 to 10 wt%; more preferably, it ranges from 0.07 to 7 wt%; the concentration of said stabilising agent preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.07 to 3 wt%.
• the concentration of said distarch phosphate preferably ranges from 0.05 to 10 wt%; more preferably, it ranges from 0.07 to 7 wt%.
• the concentration of said xanthan gum preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.07 to 3 wt%.
• Said excipient can further be a preservative, preferably a glycol, even more preferably pentylene glycol.
• the concentration of said preservative preferably ranges from 0.5 to 10%; more preferably it ranges from 0.75 to 7%.
• said excipient can be an antioxidant, preferably selected from: tocopherol, tocopherol acetate, vitamin E, vitamin C, sodium lactate and combinations thereof.
• concentration of said antioxidant preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.08 to 3 wt%.
• said excipient can be a fragrance and/or perfume, preferably selected from: linalool, limonene, geraniol, citronellol and combinations thereof.
• concentration of said fragrance and/or perfume preferably ranges from 0.005 to 10 wt%; more preferably, it ranges from 0.01 to 7 Wt%.
• a further aspect of the present invention relates to the composition of the invention which is formulated, preferably for topical use, as a cream, gel cream, gel, serum, oil, emulsion, emulsion gel (emulgel), ointment, spray or stick (such as cocoa butter).
• a further aspect of the present invention relates to the cosmetic use of the composition as described above, preferably for preventing and/or attenuating and/or combating the signs of skin aging, wherein the signs of aging are preferably selected in the group consisting of wrinkles, preferably expression wrinkles, skin spots, reddening, cracking or loss of skin tone and/or elasticity and combinations thereof.
• a further aspect of the present invention relates to the composition as described above for use as a medicament.
• a further aspect of the present invention relates to the composition as described above for use in the treatment and/or prevention of pathological conditions affecting the skin, preferably in order to prevent and/or treat skin aging, preferably reddening, irritations, topical inflammation and/or cracking.
• composition according to the present invention relates to the use of the composition according to the present invention in personal care and/or hygiene, preferably for disinfecting the skin/epidermis, more preferably for the prevention and/or treatment of infections by pathogens, preferably infections by bacteria and/or yeasts and/or moulds.
• Said pathogens are preferably selected from: Staphylococcus epidermidis, Propionibacterium acnes, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Aspergillus brasiliensis and combinations thereof.
• IL-8 proinflammatory interleukin-8
• hydroxycortisone anti-inflammatory
• TNF- a induces the maximum release of IL-8 after 72 hours of treatment and co-stimulation with hydroxycortisone is capable of partially inhibiting the release of IL-8.
• the 72-hour treatment with TNF- a was chosen in order to assess the anti-inflammatory effect of the polyphenolic concentrate.
• the 1 :200 dilution of the polyphenolic concentrate is capable of inhibiting the release of IL-8 by 78% compared to the control treated with TNF- a for 72 hours.
• the tests conducted indicate whether the reverse osmosis polyphenolic concentrate has an anti-bacterial and anti-mycotic action on various pathogens (bacteria and yeasts and moulds), in particular causes of skin diseases, such as, for example, acne.
• pathogens bacteria and yeasts and moulds
• the effect of the reverse osmosis polyphenolic concentrate was analysed in relation to the following pathogens:
• Bacteria Staphylococcus epidermidis, Propionibacterium acnes, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Yeasts: Candida albicans
• the antimicrobial activity of the concentrate was assessed with two other tests: perforation test and plate test.
• the culture plates are injected in such a way as to have an initial number of germs between 10 5 and 1.2-10 7 KBE per plate.
• the plates are incubated as described in the European Pharmacopoeia. As shown in Figures 5 and 6, the concentrate shows a good antibacterial activity and a fairly good antimycotic activity.
• the gelling agent for example hyaluronic acid
• the two phases are thus combined until obtaining a homogeneous substance.
• the pH of the solution is then adjusted so that it is neutral for human skin.
• a modified dextrin is dispersed in the polyphenolic concentrate and incubated at a temperature comprised from 70°C to 100°C°.
• the remaining water-soluble substances are added and mixed at a temperature comprised from 70°C to 100°C°.
• the substances soluble in oil are mixed so as to obtain an emulsion and melted at a temperature comprised from 70°C to 100°C°.
• a gelling agent is dispersed, for example hyaluronic acid.
• the aqueous solution is then added slowly to the emulsion and homogenized in a homogenizer, preferably a rotor-stator homogenizer.
• a homogenizer preferably a rotor-stator homogenizer.
• the emulsion obtained is cooled to room temperature ( ⁇ 30°) while mixing.
• the PH values are adjusted with the aid of lactic acids so as to render them neutral for skin and perfumes and/or fragrances are added.
• a modified dextrin is dispersed in the polyphenolic concentrate and incubated at a temperature comprised from 70°C to 100°C°.
• the remaining water-soluble substances are added and mixed at a temperature comprised from 70°C to 100°C°.
• the substances soluble in oil are mixed so as to obtain an emulsion and melted at a temperature comprised from 70°C to 100°C°.
• a gelling agent is dispersed, for example hyaluronic acid.
• the aqueous solution is then added slowly to the emulsion and homogenized in a homogenizer, preferably a rotor-stator homogenizer.
• a homogenizer preferably a rotor-stator homogenizer.
• the emulsion obtained is cooled to room temperature ( ⁇ 30°) while mixing.
• the PH values are adjusted with the aid of lactic acids so as to render them neutral for skin and perfumes and/or fragrances are added.
• the test group was made up of 40 adult female subjects.
• Each subject subsequently applied an intensive serum on the right part of the face and a face cream on the left part of the face twice a day, in the morning and evening, for a period of 4 weeks.
• a serum "A” comprising 5 wt% of the polyphenolic concentrate and a serum “B” comprising 10 wt% of the polyphenolic concentrate were applied on the right part of the face
• a face cream "A” comprising 1 wt% of the polyphenolic concentrate and a face cream “B” comprising 5 wt% of the polyphenolic concentrate on the left part of the face, twice a day, in the morning and evening, for a period of 4 weeks.
• the subjects were instructed to use exclusively the tested preparation on the tested part during the period of the test.
• An epicutaneous test performed at the end of a four-week treatment provides information not only about irritant reactions on the skin, but also about the sensitisation potential of the preparation used.
• the epicutaneous test is a model of testing for primary irritations of the skin caused by the tested product and/or any existing sensitisation against the tested product.
• the tested substances are applied in suitable concentrations occlusively on the skin.
• the epicutaneous contact with the tested product is thus only local and limited in time, intensified by the occlusive condition, which favours the absorption of the tested substances.
• the skin is examined after 24, 48 and 72 hours. The occlusion favours the penetration of the probable topical allergen through the horny layer, enabling it to reach the effector T cells, which provoke a local reaction of the immune system.
• a positive reaction to a correctly applied epicutaneous test serves as evidence of a primary irritation caused by the tested substance, but is not necessarily evidence of sensitisation. Allergic reactions of the skin are provoked through the epicutaneous test if sensitisation already exists. 5 mg/15 ⁇ of the tested product are applied undiluted on a self-adhesive patch (Curatest® F Folien-Testpflaster, Fa. Lohmann & Rauscher GmbH & Co. KG), which is applied and fixed on clinically healthy skin on the upper part of the back. The patch is removed after a 24-hour period of exposure and evaluated dermatologically and allergologically for the first time.
• a second and third evaluation takes place after 48 and 72 hours.
• the evaluation of the reaction takes place 30 minutes after the removal of the patch.
• evaluations are performed some time later. All the evaluations are performed under standardised lighting.
• the face creams A and B and the intensive serums A and B were well tolerated by a total of 40 persons tested during the four-week study period of use thereof according to dermatological and clinical criteria. No case of an undesirable or even pathological alteration of the skin occurred in the tested part.
• the epicutaneous tests did not give rise to any type of skin alteration in the tested part in any subject after 24, 48 and 72 hours.
• a and B and the intensive serums A and B do not cause undesirable skin reactions due to irritative or sensitising effects.
• 3D recording and evaluation of the surface of the human skin is an important task of dermatological examinations, from both a medical and cosmetic point of view.
• a reading of the 3D profile of the surface of the skin can be made by creating a cast of the skin (replica) or also via direct in vivo measurements.
• the so-called structured light projection technique is applied.
• a pattern of parallel stripes is projected onto the surface of the skin, which is then represented on a CCD chip.
• the 3D measurement effect is achieved because even the slightest height differences on the skin's surface create deflections of the parallel stripes. These deflections represent a qualitative and quantitative measurement for the skin profile.
• the CCD camera records them, digitises them and enters them into the computer for a quantitative interpretation.
• Mathematical algorithms originally developed and used for exact optical measurement of precision mechanical components are applied for the interpretation. Now it can also be used for 3D optical skin measurements to obtain a very precise 3D profile of the surface of the skin.
• the 3D optical skin measurement instrument PRIMOS (from: Phaseshift Rapid In vivo Measurement Of Skin) is characterised by the fact that as in the case of signal processing it applies a digital projection of structured light.
• the digital projection of light is based on the development of digital projectors with micromirrors, invented and introduced to the market in the 1990s by Texas Instruments/Dallas.
• the compact version of the PRIMOS device used consists of an optical sensor (with an integrated micromirror projector, projection and recording optics, CCD camera), a computer for measurement and data interpretation, and a mount for moving the sensor freely and taking photographs of different areas of the skin.
• a further element of the PRIMOS instrument is a software package for measurement and the interpretation of skin surface data.
• the PRIMOS instrument enables both a completely contactless measurement of skin profile data and the measurement of replicas.
• Each measurement method has advantages and disadvantages.
• anyone who is not experienced in creating replicas may easily cause minimal mechanical loads which lead to changes in the 3D micro structure.
• Direct in vivo measurement of the skin poses difficulties due to subjects "wobbling" or because of the involuntary movements listed below. The two methods can lead to different results in measuring the roughness or smoothness of the skin.
• the surface of the human skin is continually exposed to movements caused by blood circulation and the autonomic nervous system.
• movements caused by blood circulation and the autonomic nervous system For example lips, eyelids or folds
• These changes can cause different degrees of disturbance, depending on the phase of exposure to light.
• the 3D data can become completely unusable.
• a series of slight movements during the acquisition of data can still be identified relatively well in the results.
• errors caused by series of submicroscopic movements during the acquisition of data are often difficult to identify and pose the risk of distorting the results measured on the skin surface.
• 3D optical measurement are performed in order to observe the action of a medicinal or cosmetic therapy on the surface of the skin. This objective presupposes that the treated skin, both before and after treatment, must be exactly assessable from a quantitative and qualitative point of view. Given that the human skin has fairly irregular surface structure, in order to measure skin roughness it is particularly important that before and after the treatment exactly the same area of the skin is measured.
• the material used for the cast is equivalent to DIN 13 913 A 2, ISO 4823, Type 1 category B, colour: white.
• the mass After a time of preparation of 45 seconds, the mass is evenly applied without pressure on the test area and hardens after 2-3 minutes. This elastic cast can then be detached from the skin surface and is fixed lying flat on a glass plate with a solvent-free glue.
• the program creates a realistic 3D representation of the skin profile on the colour display. Afterwards, the values recorded by the computer are processed and analysed. The analysis entails the following steps:
• Skin roughness was measured in order to study the action of the face creams A and B and intensive serums A and B on 40 probands before and after 4 weeks of regular application of the preparations.
• the roughness values were measured with the aid of 3D measurements of the skin surface (skin replica).
• skin replica In the treated area, an improvement in skin roughness of -15.09 % occurred on left half of the face and -14.75 % on the right side.
• the face creams A and B and intensive serums A and B when applied according to the clinical-dermatological criteria, were very well tolerated and improved skin roughness according to standard DIN 4768ff.
• Table 8 parameters that can be visualised, analysed and compared with the VISIA® system.
• the face is illuminated with three different types of light, on the right, left and front: IntelliFlash® (standard light), polarised light and UV light (365 nm).
• IntelliFlash® standard light
• polarised light 365 nm
• Imaging with UV light enables the best interpretation and analysis of skin damage caused by the sun and visualisation of porphyrins.
• Imaging with polarised light increases contrast and saturation and reduces the reflections and glare of shiny surfaces.
• Canfield's RBX® Technology it is possible to differentiate the red and brown areas of the skin in order to perfectly visualise telangiectasia, hyperpigmentation, rosacea and acne. Data interpretation takes place automatically in the following modes:
• Feature counts Count of the frequency of a specific feature. This analysis enables a precise count of the features to be analysed (for example, evenness, pores etc.). Only the frequency is indicated, independently of the size or intensity of the feature.
• the test group is made up of 5 adult female probands.
• Table 9 Feature: Pores ("values"). Representation of the individual results measured of the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.
• Table 10 Feature: Pores ("Features count”). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.
• Table 12 Evenness ("Features count”). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.
• Table 13 Porphyrins ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.
• Table 15 Pores ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of
• Table 16 Pores ("Features count”). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.
• Table 18 Evenness ("Features count”). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.
• Table 19 Porphyrins ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of
• Table 20 Porphyrins ("Features count"): Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.
• Table 21 Pores ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of
• Table 22 Pores ("Features count”). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.
• Table 24 Evenness ("Features count”). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.
• Table 25 Porphyrins ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.
• Table 26 Porphyrins ("Features count"): Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.
• Table 27 Pores ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of
• Table 28 Pores ("Features count”). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Dermatology (AREA)
• Chemical & Material Sciences (AREA)
• General Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Medicinal Chemistry (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Epidemiology (AREA)
• Birds (AREA)
• Engineering & Computer Science (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Communicable Diseases (AREA)
• Oncology (AREA)
• Oil, Petroleum & Natural Gas (AREA)
• Gerontology & Geriatric Medicine (AREA)
• Emergency Medicine (AREA)
• Biotechnology (AREA)
• Botany (AREA)
• Microbiology (AREA)
• Mycology (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Cosmetics (AREA)
• Medicinal Preparation (AREA)
• Medicines Containing Plant Substances (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=62218063

Family Applications (1)

Country Status (3)

Families Citing this family (3)

Family Cites Families (2)

• 2018
  • 2018-01-31 IT IT201800002266A patent/IT201800002266A1/it unknown
• 2019
  • 2019-01-31 EP EP19707482.6A patent/EP3746040A1/de not_active Withdrawn
  • 2019-01-31 WO PCT/IB2019/050771 patent/WO2019150292A1/en unknown

Also Published As

Similar Documents

Legal Events